(38 days)
Not Selected
Not Found
No
The summary describes a simple plastic device for venipuncture and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as image processing and performance studies typically associated with AI/ML devices.
No
The device is described as a non-sterile reusable plastic device for routine venipuncture procedures, similar to a Vacutainer holder, which is a collection device, not a therapeutic one.
No
The device is described as a "non-sterile reusable plastic device to be used in routine venipuncture procedures." This indicates it is a tool for blood collection, not for diagnosing medical conditions. The Predicate Device is a 'VACUTAINER Brand holder', which is also a blood collection tool.
No
The device description explicitly states it is a "non-sterile reusable plastic device," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To be used in routine venipuncture procedures." This describes a procedure for collecting a sample (blood), not for performing a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description is of a "non-sterile reusable plastic device to be used in routine venipuncture procedures." This aligns with a device used for blood collection, like a needle holder or tube holder, which are not IVDs.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample, detect a substance, or provide any diagnostic information.
- Predicate Device: The predicate device is "Becton Dickinson's preamendment VACUTAINER® Brand holder." VACUTAINER holders are devices used to hold blood collection tubes during venipuncture, and they are not classified as IVDs.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely related to the collection of the specimen, not the analysis of it.
N/A
Intended Use / Indications for Use
To be used in routine venipuncture procedures
Product codes
JKA
Device Description
The VACUETTE & Multi-use Holder is non-sterile reusable plastic device to be used in routine venipuncture procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
1974873
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FEB 5, 1998
Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner VACUETTE Multi-use Holder. The VACUETTE & Multi-use Holder is non-sterile reusable plastic device to be used in routine venipuncture procedures.
Greiner is claiming substantial equivalence to Becton Dickinson's preamendment VACUTAINER® Brand holder. The VACUETTE® holder is manufactured from polypropylene plastic as is the Becton Dickinson VACUTAINER® Brand holder. Both devices have the same intended use.
Greiner's 510(k) has been submitted on December 23, 1997 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland 21014 (T: 410-836-8228).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with three flowing lines representing hair or a head covering.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FFB - 5 19
Douglas L. Harris Managing Director · Greiner Meditech, Inc. 260 Gateway Drive, Suite 17A P.O. Box 943 Bel Air, Maryland 21014
K974873 Re : VACUETTE® Multi-Use Holder Requlatory Class: II Product Code: JKA Dated: December 22, 1997 December 29, 1997 Received:
Dear Mr. Harris: ......
regulations.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set " forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known) __
Device Name: VACUETTE & Multi-Use Holder
Indications for Use: To be used in routine venipuncture procedures
Prescription _________________________________________________________________________________________________________________________________________________________________
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 974873